Strengthening Ethical Review Capacity in Democratic Republic of Congo (SERC-DRC)

加强刚果民主共和国的道德审查能力 (SERC-DRC)

• 批准号: 10321965
• 负责人: ADNAN A HYDER
• 金额: $ 10.05万
• 依托单位: GEORGE WASHINGTON UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-05-19 至 2023-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10321965
• 关键词: Acquired Immunodeficiency Syndrome; Administrative Efficiency; Administrator; Africa; Africa South of the Sahara; African; Applied Skills; Assessment tool; Attention; Awareness; Bioethics; Biomedical Research; Caring; Childhood; Collaborations; Communication; Complex; Country; Democratic Republic of the Congo; Educational process of instructing; Ensure; Equipment; Ethical Issues; Ethical Review; Ethics; Foundations; Goals; HIV; HIV prevention trials network; Human; Infrastructure; Institution; Institutional Policy; Institutional Review Boards; Joints; Knowledge; Leadership; Mentors; Mission; Modeling; Needs Assessment; Participant; Performance; Persons; Policies; Positioning Attribute; Procedures; Process; Protocols documentation; Public Health Schools; Research; Research Ethics; Research Infrastructure; Resources; Schools; Site; Structure; System; Telephone; Time; Training; Training and Infrastructure; United States National Institutes of Health; Universities; Visit; Vulnerable Populations; Washington; Work; experience; global health; human subject protection; improved; infrastructure development; low and middle-income countries; marginalized population; member; operation; professor; programs; response; skills; sound; tool; webinar

Project Summary/Abstract The growing research enterprise in low and middle-income countries (LMICs) has brought attention to the need for high quality research infrastructure, especially institutional review boards (IRBs) for the protection of human subjects. Sub-Saharan Africa is increasingly the site of HIV research which raises particularly complex and challenging ethical issues involving vulnerable and marginalized populations, fair benefits to participants, and appropriate standards of care. Under such circumstances, sound ethical review requires both experience and sophistication, along with understanding of the local context, to adequately protect participants. At the same time, given that much HIV research is multi-site, it also is essential that reviews occur with some degree of efficiency. In addition, building capacity for local ethics review and ensuring adequate protection of human subjects in HIV research advances not only the global HIV response but biomedical research more broadly. The specific aims of the George Washington University (GWU)-Kinshasa University (KU) Strengthening Ethical Review Capacity in Democratic Republic of Congo (SERC-DRC) proposed project are: Aim 1: To strengthen ethics knowledge and reasoning skills of the KU School of Public Health (KH-SPH) Institutional Review Board: through KUSPH-IRB leadership and key members attending a GWU one-month intensive program, ethics seminars at KUSPH, and a joint webinar program. Aim 2: To enhance knowledge of IRB administration and standard operating procedures at KUSPH-IRB: through intensive technical assistance, brief attachments at GWU IRB, local support by African consultants, and transfer of best practices from GWU. Aim 3: To improve efficiency and performance of KUSPH-IRB: by intensive mentoring including in-person visits from African experts; biweekly support phone calls; in-person visit from GWU-IRB experts; implementation of a tracking and quality system; support for staff and key equipment. Aim 4: To evaluate performance of the KUSPH-IRB over a 3-year period: through administration of an existing knowledge and skills assessment tool for members/staff; and administration of an existing IRB needs assessment and efficiency tool for KUSPH-IRB. By the end of this project, we expect to have strengthened the administrative infrastructure of KUSPH-IRB operations and in turn improved its administrative efficiency, reduced review times, and improved the quality of the review process. We also expect to increase the knowledge and skills of all current IRB members such that changes in quality of ethical review can be sustained. The proposed collaboration will build upon a strong GWU-KUSPH partnership, our 20 years of experience in developing ethics capacity in Africa, our experience with NIH-Fogarty programs, and our expertise in global health in Africa, to elevate KUSPH-IRB as a regional leader in research ethics review.

项目摘要/摘要 低收入和中等收入国家（LMIC）不断增长的研究企业引起了人们的注意 用于高质量的研究基础设施，尤其是机构审查委员会（IRB）以保护人类 主题。撒哈拉以南非洲越来越成为艾滋病毒研究的地点，这使得特别复杂， 挑战涉及脆弱和边缘化人群，公平利益的道德问题以及 适当的护理标准。在这种情况下，合理的道德审查需要经验和 精致，以及对当地环境的理解，以充分保护参与者。同样 鉴于许多艾滋病毒研究是多站点的时间，因此评论以一定程度的评论至关重要 效率。此外，建立当地道德审查的能力并确保对人类的充分保护 艾滋病毒研究的受试者不仅可以更广泛地促进全球艾滋病毒反应，而且可以提高生物医学研究。 乔治华盛顿大学（GWU） - 金沙萨大学（KU）加强的具体目的 刚果民主共和国（SERC-DRC）提议的项目的道德审查能力是：目标1： 加强KU公共卫生学院（KH-SPH）的道德知识和推理能力 机构审查委员会：通过Kusph-IRB领导和主要成员参加GWU一个月 密集计划，Kusph的道德研讨会和联合网络研讨会计划。目标2：增强知识 KUSPH-IRB的IRB管理和标准操作程序：通过密集的技术 协助，GWU IRB的简短附件，非洲顾问的本地支持以及最佳实践转移 来自GWU。目标3：提高Kusph-irb的效率和性能：通过密集指导 包括非洲专家的面对访问；双周支持电话； Gwu-irb的亲自访问 专家；实施跟踪和质量系统；支持员工和关键设备。目标4：到 评估Kusph-irb在3年内的性能：通过管理现有 成员/员工的知识和技能评估工具；和管理现有的IRB需求 KUSPH-IRB的评估和效率工具。到该项目结束时，我们希望加强 Kusph-IRB运营的行政基础设施，进而提高其行政效率， 减少了审核时间，并提高了审核过程的质量。我们还期望增加 所有当前IRB成员的知识和技能，以使道德审查质量的变化可以是 持续。拟议的合作将以强大的GWU-KUSPH合作伙伴关系为基础，这是我们20年的 在非洲发展道德能力的经验，我们在NIH-Fogarty计划方面的经验以及我们的 非洲全球健康方面的专业知识，以提升Kusph-IRB为研究伦理学评论的区域领导者。